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Safety and Efficacy of a Glaucoma Drug Delivery System

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose Device
Low Dose Device
Placebo Device
Sponsored by
Vistakon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Man or woman 21 years of age or greater
  • must have open angle glaucoma or ocular hypertension.
  • Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

  • Previous glaucoma intraocular surgery or refractive surgery.
  • Planned contact lens use during the study.
  • Clinically significant ocular or systemic disease that might interfere with the study.
  • Use of chronic corticosteroids by any route.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High Dose Device

Low Dose Device

Placebo Device

Arm Description

device worn continuously for 14 days

device worn continuously for 14 days

device worn continuously for 14 days

Outcomes

Primary Outcome Measures

Visual Acuity - Right Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Visual Acuity - Left Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary Outcome Measures

Intraocular Pressure (IOP)

Full Information

First Posted
January 9, 2009
Last Updated
February 18, 2015
Sponsor
Vistakon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00824720
Brief Title
Safety and Efficacy of a Glaucoma Drug Delivery System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vistakon Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose Device
Arm Type
Experimental
Arm Description
device worn continuously for 14 days
Arm Title
Low Dose Device
Arm Type
Experimental
Arm Description
device worn continuously for 14 days
Arm Title
Placebo Device
Arm Type
Placebo Comparator
Arm Description
device worn continuously for 14 days
Intervention Type
Drug
Intervention Name(s)
High Dose Device
Intervention Description
inserted for 14 days
Intervention Type
Drug
Intervention Name(s)
Low Dose Device
Intervention Description
inserted for 14 days
Intervention Type
Device
Intervention Name(s)
Placebo Device
Intervention Description
inserted for 14 days
Primary Outcome Measure Information:
Title
Visual Acuity - Right Eye
Description
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
at 14 days
Title
Visual Acuity - Left Eye
Description
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Time Frame
at 14 days
Secondary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Time Frame
from baseline to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Man or woman 21 years of age or greater must have open angle glaucoma or ocular hypertension. Corrected visual acuity in each eye of 20/200 or better. Exclusion Criteria: Previous glaucoma intraocular surgery or refractive surgery. Planned contact lens use during the study. Clinically significant ocular or systemic disease that might interfere with the study. Use of chronic corticosteroids by any route.
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
USA
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of a Glaucoma Drug Delivery System

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